A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 to Aflibercept in Participants with Diabetic Macular Edema

The primary objective of this study is to evaluate the efficacy of 2686 μg EYP-1901 intravitreal inserts on changes in best corrected visual acuity (BCVA) compared to aflibercept treatment in participants with diabetic macular edema (DME). 5

The secondary objectives include:

• Evaluation of the efficacy of EYP-1901 inserts regarding injection burden.
• Assessment of changes in retinal thickness.
• Evaluation of additional BCVA outcomes.
• Determination of the need for supplemental injection treatment following the administration of EYP-1901 inserts.
• Evaluation of DME progression following administration.

This study involves a total of 188 participants diagnosed with diabetic macular edema. The study population includes both male and female subjects, with age ranges corresponding to codes 3 and 4. Eligible participants must have a diagnosis of diabetes mellitus that has remained stable for at least 3 months and is managed via oral antihyperglycemic agents, insulin, or injectable medications. A required laboratory parameter is a hemoglobin A1c level of less than 10% at the time of screening. Additionally, subjects must have a prior diagnosis of macular edema associated with diabetic retinopathy. Participants are required to utilize appropriate contraception if applicable and demonstrate the ability to adhere to all scheduled assessments and restrictions.

This Phase 3, multicenter, prospective, randomized, double-masked, parallel-group study is designed to evaluate the efficacy of vorolanib, an intravitreal implant, compared to aflibercept in participants with diabetic macular edema. The primary objective is to assess changes in best corrected visual acuity over 56 weeks. Secondary endpoints include the frequency of required injections, changes in retinal thickness, and the rate of improvement in the medical condition. The study sequence begins with a screening visit to assess eligibility, followed by scheduled follow-up visits to monitor clinical outcomes. The total duration of participant involvement includes a 56-week treatment period, with additional monitoring of injection requirements up to 88 weeks. An end-of-study visit will conclude the assessment period.

The experimental treatment consists of vorolanib, administered as an implant. The dosage is 2686 µg delivered via intravitreal injection.

The comparator treatment involves aflibercept, provided as a solution for injection in a pre-filled syringe at a dose of 2 mg. This substance is administered through intravitreal use.

The study evaluates these interventions in participants diagnosed with diabetic macular edema.

The efficacy of EYP-1901 in participants with diabetic macular edema is assessed through several parameters. The primary endpoint is the change in best corrected visual acuity (BCVA) over 56 weeks compared to aflibercept. Secondary endpoints include the frequency of required injections during the 56-week treatment period and changes in retinal thickness from the baseline treatment. Additional assessments involve the percentage of participants maintaining, gaining, or losing a specific number of letters on an eye chart over time.

Further efficacy evaluations include the following:

• The percentage of participants requiring supplemental aflibercept injections up to week 88.
• The total number of additional aflibercept injections required by week 88.
• The rate and percentage of improvement in the clinical status of the disease over time.